MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE INJECTOR NM600/610; INJECTOR AND SHEATHSET

Model Number	NM-600L-0521
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, because the subject device was discarded by the user.Therefore, the exact cause of the reported event could not be conclusively determined.The manufacturing record was reviewed and found no irregularities.This type of the event is most likely related to the operator's technique.Based on the past similar cases, omsc presumes that the event occurred due to either of the following possible causes.1) the bending of the tube occurred due to applying bending load to the tube when the device was inserted into the endoscope.The frictional resistance between the tube and the needle tube increased due to the bending of the tube.The needle could not be retracted into the tube.2) the bending of the tube occurred due to applying bending load to the tube when the device was inserted into the endoscope.The frictional resistance between the tube and the needle tube increased due to the bending of the tube.The jointing part of the needle tube slipped toward the distal end when the slider was pulled.The needle could not be retracted into the tube.The instruction manual of the device has already warned as follows; a) when inserting the instrument into the endoscope, retract the needle into the sheath, hold the instrument close to the biopsy valve, and keep it as straight as possible relative to the biopsy valve.Otherwise, the instrument could be damaged.B) stop using the instrument if the insertion portion bends excessively during use.This could result in malfunction, such as failing to extend the needle or inject a fluid.
Event or Problem Description
During a hemostasis for gastric varices bleeding, the subject device was used.Although the user tried to retract the needle of the subject device, the needle could not be retracted into the tube.The user removed the subject device and endoscope from the patient.The intended procedure was completed.No patient injury was reported.This is the report regarding the inability to retract the needle.

• Brand Name: SINGLE USE INJECTOR NM600/610
• Common Device Name: INJECTOR AND SHEATHSET
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 7976997
• Report Number: 8010047-2018-02007
• Device Sequence Number: 1195307
• Product Code: FBK
• UDI-Device Identifier: 04953170377570
• UDI-Public: 04953170377570
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K153625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NM-600L-0521
• Device Lot Number: 65K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1